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　　The Measures for the Rapid Review and Approval of Medical Devices in Beijing have been deliberated and adopted at the 5th Director’s Office Meeting of Beijing Food and Drug Administration in 2018, and are hereby issued, please follow them.

Beijing Food and Drug Administration

February 9, 2018

Measures of Beijing Municipality for the Examination and Approval of Rapid Review of Medical Devices

　　the first　According to the requirements of the Notice of the General Office of the State Council City, the General Office of the Central Committee of the CPC on Printing and Distributing Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Medicines and Medical Devices (Z.Z. [2017] No.42), according to the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of the Registration of Medical Devices, the Measures for the Administration of the Registration of In-vitro Diagnostic Reagents and the Policy Matters of the Food and Drug Administration on Supporting the Supervision and Industry Development of Zhongguancun, In order to encourage innovation, encourage the transformation of scientific and technological achievements, improve the efficiency of examination and approval of medical devices in Beijing, and promote the rapid development of medical device industry in Beijing, these measures are formulated.

　　the second　For Beijing medical device products that meet one of the following circumstances, the applicant may apply to Beijing Food and Drug Administration for approval of innovative medical devices:

　　(1) Having relevant national and Beijing scientific research projects, and the patents of core technology inventions involved have been made public or authorized.

　　(2) The invention patent of the core technology, which is the first in Beijing, has the leading product technology in China, has great clinical application value and is involved, has been made public or authorized.

　　(3) Patents for core technology inventions produced by key enterprises in Beijing, such as the 100-thousand-cultivation project and the Beijing Biomedical Industry Leap-forward Development Project (G20), have been made public or authorized.

　　(four) included in the national or Beijing major science and technology projects, key research and development plans;

　　Article　For the implementation of innovative medical devices in accordance with the provisions of Article 2 of these Measures, the person in charge shall be responsible, and early intervention, whole-process counseling, priority registration and testing, priority review and approval, priority registration quality system verification and priority production license matters shall be handled. See Annex 1 for the application requirements of innovative medical devices in Beijing.

　　Article 4　According to the application of the enterprise, Beijing Medical Device Technology Evaluation Center provides pre-consulting services for innovative clinical trial schemes of medical devices that meet the requirements of Article 2 of these Measures.

　　Article 5　For innovative medical devices that meet the requirements of Article 2 of these Measures, enterprises may entrust Beijing medical device manufacturing enterprises to produce products, and the medical device production license of the entrusted party shall obtain the corresponding production scope.

　　Article 6　For innovative medical devices, a cross-disciplinary joint evaluation method can be implemented.

　　Article 7　For innovative medical devices in Beijing that have been listed in the first registration cycle, all adverse medical device events of the product shall be reported and a summary report on monitoring, analysis and evaluation of adverse medical device events shall be submitted to the Beijing medical device adverse event monitoring technical institution and the food and drug administration department in the jurisdiction every year.

　　Article 8　For Beijing medical device products that meet one of the following circumstances, the applicant may apply to Beijing Food and Drug Administration for priority approval of medical devices:

　　(1) It is urgently needed in clinic, and there is no product of the same variety approved for registration in China;

　　(two) the varieties of medical devices belonging to the Beijing medical materials reserve unit and the unique and frequently-occurring diseases of children or disabled people;

　　(3) Diagnosing or treating rare diseases with obvious clinical advantages;

　　(four) for the treatment of serious life-threatening diseases and there is no effective treatment, as well as public health and other urgent needs;

　　(5) Intelligent rehabilitation apparatus;

　　(six) Beijing innovative medical device products to improve the production process.

　　Article 9　For medical device products that meet the requirements of Article 8 of these Measures, priority shall be given to registration and testing, priority shall be given to review and approval, priority shall be given to the verification of registration quality system, and priority shall be given to the handling of production licensing matters. Please refer to Annex 2 for the application requirements for priority approval of medical devices in Beijing.

　　Article 10　For the change of medical device registration license matters, the specification of product name, product technical requirements, scope of application, etc. does not involve substantial content changes, which can be combined with the renewal of registration.

　　Article 11　If the recommended standards, the guiding principles of registration technology review and the norms of registration technology review change in the renewal registration of medical devices, the enterprise may not change the licensing matters.

　　Article 12　If the specifications and models of medical devices are reduced, they can be handled in accordance with the registration procedures.

　　Article 13　For in vitro diagnostic reagent products, it is not necessary to submit analytical performance evaluation data, risk analysis data related to product changes, product technical requirements, product specifications and label samples by increasing the packaging specifications with different loading quantities (only the loading differences) and adding the changes of licensing items for applicable models with the same degree of automation. The time limit for registration review was shortened to 30 working days.

　　On the basis of strictly implementing the requirements of the quality system, the enterprise completes relevant risk analysis, performance evaluation, design changes, etc., and keeps records for future inspection.

　　Article 14　Those who fail to apply for registration renewal six months before the expiration of the validity period shall be registered for the first time. If the product has not changed, the latest registered clinical data, registration test report and system verification results may be submitted.

　　Article 15　Formulate the technical guidelines for clinical evaluation of medical devices in Beijing, study the comparison methods of similar medical devices, and simplify the clinical evaluation data of the same variety of medical devices.

　　Article 16　Beijing Medical Device Technology Evaluation Center has established a communication mechanism for enterprises to solve the difficult problems encountered by enterprises in the registration and evaluation stage of medical devices.

　　Article 17　Integrate the on-site inspection of the registered quality system verification and the on-site inspection of the production license. In principle, after the on-site inspection of the new product registration quality system verification has passed and the medical device registration certificate has been obtained, the products added to the Medical Device Production License can be exempted from the on-site inspection.

　　Article 18　For enterprises that have obtained production licenses, applying for the registration of Class II medical devices that do not involve new methodology or new technology may be exempted from on-site inspection or optimization of on-site inspection items and processes in the process of registration quality system verification.

　　Article 19　If the contents of the change of medical device registration license items do not involve the change of production process, the on-site inspection may be exempted or the on-site inspection items and processes may be optimized in the process of registration quality system verification.

　　Article 20　For those who have passed the on-site inspection of registered quality system verification at least once in two years, and the products applied for inspection this time have the same or similar working principles and expected uses compared with those that have passed the inspection, and have basically the same structural composition, production conditions and production processes, they are exempted from on-site inspection or optimized on-site inspection items and processes in the process of registered quality system verification.

　　Article 21　If the production address is reduced and the production process changes are not involved, the on-site inspection can be exempted or the on-site inspection items and processes can be optimized during the approval of the production license.

　　Article 22　In principle, on-site re-inspection is not required if no key project defects are found in the on-site inspection of the registered quality system, and the number of general project defects accounts for less than 10% of the total number of general projects that should be inspected.

　　Article 23　If the on-site inspection of the production license requires the enterprise to carry out rectification, the enterprise may be required to submit rectification report and rectification data according to the situation of the on-site inspection and the rectification items, and the on-site re-inspection is not required if it can be verified through the data.

　　Article 24　Optimize the registration examination and approval procedures, and cancel the following examination and review links in the administrative examination and approval of medical device registration:

　　(1) First registration of Class II medical device products (including in-vitro diagnostic reagents) that fully implement the guiding principles of product registration technology review issued by china food and drug administration or the product registration technology review norms issued by Beijing Food and Drug Administration;

　　(two) the second class of medical devices (including in vitro diagnostic reagents) continued registration;

　　(three) the second kind of medical devices (excluding in vitro diagnostic reagents) product description changes;

　　(four) the second kind of medical devices (including in vitro diagnostic reagents) product registration certificate error correction.

　　Article 25　These Measures shall not apply to domestic applicants who apply for approval of innovative medical devices to Beijing Food and Drug Administration according to the Notice of the General Administration of Food and Drug Administration on Printing and Distributing Special Approval Procedures for Innovative Medical Devices (Trial) (No.13 [2014] of the Food and Drug Administration).

　　Article 26　These Measures shall be interpreted by the Beijing Food and Drug Administration.

　　Article 27　These Measures shall come into force as of the date of promulgation. The Measures for the Examination and Approval of Medical Devices in Beijing (Trial) issued on August 11, 2016 (Beijing Food and Drug Administration [2016] No.36) was abolished at the same time.

　　Attachment: 1. Requirements for reporting innovative medical devices in Beijing.

　　 　 　 　2. Requirements for priority examination and approval of medical devices in Beijing

Annex 1

Requirements for reporting innovative medical devices in Beijing

　　In order to standardize the application for innovative medical devices in Beijing and improve the quality of application materials, this application requirement is formulated in accordance with the Measures for the Examination and Approval of Rapid Medical Devices in Beijing.

　　I. Application materials for innovative medical devices in Beijing

　　(a) Beijing innovative medical device review application form (Annex 1)

　　The applicant shall truthfully fill in all the contents.

　　The contents filled in the product performance structure and composition, main working principle/action mechanism and expected use should reflect all the important information of product characteristics, be concise and to the point, use standardized and professional terms, and avoid ambiguity.

　　(2) Relevant information of previous applications for innovative medical device approval (approval) (if applicable)

　　If the product has applied for innovative medical device products from china food and drug administration or Beijing Food and Drug Administration, for the innovative medical devices that have been applied for again, copies of previous notices shall be provided, and explanations on product changes and improvement of application materials shall be submitted.

　　(3) A photocopy of the business license of the enterprise to which it applies.

　　(four) the intellectual property rights of the products and the supporting documents.

　　1. Provide a description of the intellectual property rights of the core technology of the innovative medical device applied for. If there are many invention patents, it is suggested to display the information such as the name of the invention patent, the patentee and the patent status in a list.

　　2. Provide relevant intellectual property documents.

　　(1) If the applicant has obtained the patent right for invention, it is required to provide the original copy of the patent power of attorney, the patent claim, the specification and the copy of the patent register signed by the applicant.

　　(2) If the applicant has obtained the right to use the invention patent in China through the transferee according to law, in addition to submitting the copy of the patent authorization, patent claim, specification and patent register held by the patentee, it is also necessary to provide the original Certificate of Filing the Patent License Contract issued by the patent administrative department.

　　(3) If the application for a patent for invention has been made public by the patent administration department of the State Council and is not authorized, it is necessary to provide a copy of the proof document of the publication of the invention patent signed by the applicant (such as the notice of publication of the application for a patent for invention, the notice of publication of the application for a patent for invention and the notice of entry into the substantive examination stage, etc.) and a copy of the published version of the claim and specification. In the process of examining an application for a patent for invention, if the patent claim and specification are modified at the request of the patent examination department, the modified text shall be submitted; Where the patentee changes, the certifying documents issued by the competent patent department, such as a copy of the notice of conformity, shall be submitted.

　　(V) Summary of product development process and results

　　Summarize the original intention of product research and development, laboratory research, animal experimental research, clinical research and results, and submit a comprehensive report on product research and development including design input, design verification and design output. Information on patient selection criteria, as well as parameters to be monitored and factors to be considered during use.

　　(6) Product technical documents, which shall at least include:

　　1. The intended use of the product;

　　(1) It should be made clear that the treatment and diagnosis expected to be provided by the product conform to the purpose defined in Article 76 of the Regulations on the Supervision and Administration of Medical Devices, and the applicable medical stage (such as monitoring and rehabilitation after treatment) can be described;

　　(2) explain whether the product is used once or repeatedly;

　　(3) A description of the equipment expected to be used in combination with it;

　　(4) Information of the target patient population (such as adults, children or newborns).

　　2. Working principle/action mechanism of the product;

　　Elaborate the working principle/mechanism of the product to achieve its expected use, and provide relevant basic research data.

　　3. Make clear the main technical indexes of products and the basis for determination, the index requirements of main raw materials and key components, the main production process and flow chart, and the inspection methods of main technical indexes.

　　(seven) certification documents of product innovation, which shall at least include:

　　1. Novelty retrieval report issued by information or patent retrieval institutions.

　　It should be a sci-tech novelty report issued by information retrieval institutions in China or a novelty report issued by patent retrieval institutions. The contents of the report should be able to prove the innovation point, innovation level and reasons of the product. The novelty retrieval report is valid for one year.

　　2. Summary of academic papers, monographs and documents published in core journals that can fully explain the clinical application value of products (if any)

　　Can provide product literature, but also provide overseas literature of similar products.

　　3. Analysis and comparison of the application of similar products listed at home and abroad.

　　(1) Provide a description of the retrieval of similar products that have been listed in China. Generally, it should include the retrieval database, retrieval date, retrieval keywords and the results retrieved by each keyword, and analyze the differences between the applied innovative medical devices and similar products on the market in terms of working principle/mechanism.

　　(2) Provide an explanation of the application of similar products listed overseas, compare and analyze the similarities and differences with this product, and provide comparative analysis data to support this product to be at the international leading level in technology.

　　4. The innovative content of the product and its remarkable value in clinical application.

　　(1) Overview of innovative medical devices applied for.

　　This paper expounds the innovative contents of the applied medical device, and discusses that the device has been significantly improved in terms of safety, effectiveness and economy compared with the existing products or treatment methods through innovation, and has significant clinical application value.

　　(2) Provide relevant supporting materials.

　　(eight) product safety risk management report.

　　1. Based on the research results of the risk management process carried out by the product.

　　2. Prepared according to YY/T 0316 "Application of Medical Device Risk Management to Medical Devices".

　　(9) Product description (sample draft).

　　It shall comply with the relevant requirements in the Regulations on the Administration of Instructions and Labels of Medical Devices (Order No.6 of the General Administration).

　　(ten) other documents that prove that the product conforms to Article 2 of the Measures for the Examination and Approval of Medical Devices in Beijing.

　　1. If the product or its core technology has won national and Beijing municipal science and technology awards, please explain and submit copies of relevant supporting documents;

　　2. The approval certificate of key supporting enterprises in Beijing, such as the 100 thousand cultivation project and the Beijing biomedical industry leap-forward development project (G20).

　　3 included in the national or Beijing major science and technology projects, key research and development plan documents.

　　(eleven) the self-assurance statement of the authenticity of the submitted materials.

　　Second, the format requirements

　　(a) the application materials shall be compiled by the applicant, and the documents shall be printed on A4 paper, arranged in the order specified in this acceptance requirement and bound into a book.

　　(two) there should be a list of submitted materials, including the first and second titles of the application materials. The data corresponding to each secondary heading shall be separately numbered.

　　(3) Unless otherwise specified, the application materials for the review of innovative medical devices in Beijing shall be original and signed by the applicant. "Signature" refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise.

　　(four) if the application materials are in photocopy, the photocopy shall be clear and consistent with the original. Color pictures and charts shall be provided with color copies. If the original application materials have been submitted in the previous application for examination of innovative medical devices, a copy signed by the applicant can be provided, and the applicant will issue a document stating the acceptance number of the application materials where the original application materials are located.

　　(5) The application materials shall be in Chinese. If the original text is in a foreign language, there should be a Chinese translation.

　　Third, the review process

　　To apply for innovative medical device products in our city, after the above materials are prepared, they shall be reported to the Medical Device Registration and Supervision Department of the Municipal Bureau (hereinafter referred to as the "Device Department"), and the Device Department shall formally review the application materials, and issue a receipt document (Annex 2) within 5 working days; The device will be reviewed by relevant experts within 40 working days, and the applicant and product name will be publicized on the website of Beijing Food and Drug Administration for 10 working days for the varieties to be included in Beijing’s innovative medical devices. If there is no objection after the publicity period, a final review opinion will be issued, and a notice of review of innovative medical devices in Beijing (Annex 3) will be made to inform the applicant in writing.

　　Attachment: 1. Application Form for Review of Innovative Medical Devices in Beijing

　 　 　 　　2. Beijing Innovative Medical Devices Review Receipt Certificate

　 　 　 　　3. Notice of Review Opinions on Innovative Medical Devices in Beijing

Annex 1 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Annex 2 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Beijing Innovative Medical Device Review Receiving Material Voucher

(first copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of innovative medical devices in Beijing. After formal examination, the application materials are complete and it is decided to accept it. A total of _ _ pieces of materials were received.

　　Tel: 010-83979525

　　Receiver’s signature: year month day

Beijing Innovative Medical Device Review Receiving Material Voucher

(second copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of innovative medical devices in Beijing. After formal examination, the application materials are complete and it is decided to accept it. A total of _ _ pieces of materials were received.

　　Tel: 010-83979525

　　Signature of the applicant: year month day

Annex 3 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Notice of Beijing Municipality on Review Opinions of Innovative Medical Devices

　　(No.:_ _ _ _ _)

　　The application for examination of innovative medical devices in Beijing submitted by your company (receiving material number:)

　　Performance structure and composition:

　　Main working principle/mechanism:

　　The conclusion of the review is:

.

　　I hereby inform you.

(Seal)

Date:

Annex 2

Requirements for Priority Approval and Declaration of Medical Devices in Beijing

　　In order to standardize the application for priority approval of medical devices and improve the quality of application materials, this application requirement is formulated in accordance with the Measures of Beijing Municipality for Rapid Review and Approval of Medical Devices (Revised).

　　First, Beijing gives priority to the examination and approval of medical device application materials.

　　(1) Application Form for Priority Approval of Medical Devices (Annex 1)

　　Clearly explain the circumstances specified in Article 14 of the Measures for the Rapid Review and Approval of Medical Devices in Beijing (Revised), and briefly describe the reasons for priority approval.

　　(two) a copy of the application form for registration of medical devices.

　　(three) in accordance with the "Beijing medical device rapid review and approval measures" eighth cases of medical device priority approval application, should provide information according to the following requirements:

　　1 clinical needs, and there is no product of the same variety approved for registration in China.

　　(1) Summary of the clinical treatment status of the indications of this product, explaining the reasons for urgent clinical need;

　　(2) The overseas approval and clinical use of this product and similar products;

　　(3) Provide a description of the search, which proves that there are no related products of the same variety approved for registration in China at present, and there is no equivalent alternative diagnosis or treatment method at present.

　　2. The medical device reserve varieties belonging to the Beijing medical material reserve unit and the medical device varieties used by children or disabled people with unique and multiple diseases.

　　(1) the certificate of entering the catalogue of medical material reserve units in Beijing;

　　(2) The indication of this product belongs to the supporting data of unique and frequently-occurring diseases of children or disabled people;

　　(3) Summary of the clinical treatment status of this indication;

　　(4) Description and relevant supporting materials proving that the product is specially used for diagnosing or treating unique and frequently-occurring diseases of children or disabled people, and has obvious clinical advantages compared with existing products or treatment methods.

　　3 diagnosis or treatment of rare diseases, and has obvious clinical advantages.

　　(1) Incidence data of the indications of this product and relevant supporting data;

　　(2) Supporting data to prove that the indication is a rare disease;

　　(3) Summary of the clinical treatment status of this indication;

　　(4) Description of the obvious clinical advantages of this product compared with the existing products or treatment methods and relevant supporting materials.

　　4 for the treatment of serious life-threatening diseases and there is no effective treatment, as well as public health and other urgent needs.

　　(1) To prove that the indication belongs to the urgently needed supporting information for treating diseases that are seriously life-threatening and have no effective treatment methods, and public health;

　　(2) Summary of the clinical treatment status of this indication;

　　(3) the product has obvious clinical advantages over the existing products or treatment methods, and relevant supporting materials.

　　5. Intelligent rehabilitation apparatus

　　(1) Medical devices that meet the definition of intelligent rehabilitation devices in the "Thirteenth Five-Year Plan for Scientific and Technological Innovation of Health Industry" (No.149 [2017] of National Science and Technology Development Agency);

　　(2) Summary of the clinical treatment status of this indication;

　　(3) the product has obvious clinical advantages over the existing products or treatment methods, and relevant supporting materials.

　　6. Improve the production process of innovative medical device products in Beijing.

　　(1) Notice of Review Opinions on Innovative Medical Devices in Beijing;

　　(2) Description of production process changes of new and old products.

　　(4) A self-assurance statement on the authenticity of the submitted materials.

　　Second, the format requirements

　　(a) the application materials shall be compiled by the applicant, and the documents shall be printed on A4 paper, arranged in the order specified in this acceptance requirement and bound into a book.

　　(two) there should be a list of submitted materials, including the first and second titles of the application materials. The data corresponding to each secondary heading shall be separately numbered.

　　(3) Unless otherwise specified, the application materials for the examination and approval of priority medical devices in Beijing shall be original and signed by the applicant. "Signature" refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise.

　　(four) if the application materials are in photocopy, the photocopy shall be clear and consistent with the original. Color pictures and charts shall be provided with color copies. If the original application materials have been submitted in the previous priority examination and approval of the medical device application, a copy signed by the applicant can be provided, and the applicant will issue a document stating the acceptance number of the application materials where the original application materials are located.

　　(5) The application materials shall be in Chinese. If the original text is in a foreign language, there should be a Chinese translation.

　　Third, the review process

　　To apply for the priority approval of medical device products in our city, after the above materials are prepared, they shall be reported to the Medical Device Registration and Supervision Department of the Municipal Bureau (hereinafter referred to as the "Device Department"), and the Device Department shall conduct a formal review of the application materials, and issue a receipt document (Annex 2) within 5 working days; The device shall be reviewed by relevant experts within 40 working days, and the applicant and product name shall be publicized on the website of Beijing Food and Drug Administration for 10 working days for the varieties of medical devices to be approved in Beijing. If there is no objection after the publicity period, a final review opinion will be issued, and a notice (Annex 3) for the review of medical devices with priority approval in Beijing will be made, and the applicant will be informed in writing.

　　Attachment: 1. Application Form for Priority Approval of Medical Devices in Beijing

　 　 　 　　2. Beijing Municipality gives priority to the examination and approval of medical devices, and receives the certificate of materials.

　　 　 　 　3. Notice of Beijing Municipality on Priority Examination and Approval of Medical Devices

Annex 1 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Annex 2 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Beijing Municipality gives priority to the examination and approval of medical devices.

(first copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of medical devices with priority approval in Beijing. After formal examination, the application materials are complete and it is decided to accept it. Total materials received　Pieces.

　　Tel: 010-83979525

　　Receiver’s signature: year month day

Beijing Municipality gives priority to the examination and approval of medical devices.

(second copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of medical devices with priority approval in Beijing. After formal examination, the application materials are complete and it is decided to accept it. Total materials received　Pieces.

　　Tel: 010-83979525

　　Signature of the applicant: year month day

Annex 3 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Notice of Beijing Municipality on Priority Examination and Approval of Medical Devices

　　(No.:_ _ _ _ _)

　　Your application for the examination of medical devices in Beijing with priority approval (receiving material number:)

　　Performance structure and composition:

　　Main working principle/mechanism:

　　The conclusion of the review is:

.

　　I hereby inform you.

(Seal)

Date:

Profile picture: Russian President Vladimir Putin

　　　　The British media recently revealed that some powerful people in the Russian government hope that Putin can re-serve as Russian president one year after the end of his presidency in March next year. The analysis believes that Putin’s political achievements during his presidency give him reason to become president again.

　　　　Is expected to serve as president until 2023.

　　　　Russian political "power tycoons" composed of former KGB officials expressed their hope that Putin will serve as president for at least another eight years, and even continue until 2023 if possible. Members of this power group include Igor Xie Xin, deputy director of the President’s Office, and Victor Ivanov, Putin’s senior adviser. These officials believe that once Putin leaves office, they are likely to be "kicked out" of the Kremlin.

　　　　Last week, Putin expressed the possibility of becoming Russian prime minister in the future, which surprised his aides. However, according to the plan of the "power tycoons", Putin will return to the presidency after a short term as prime minister. Because there is a short interval between the second and third terms, this practice is not unconstitutional. Once in the Kremlin again, Putin will be able to continue to legally complete the other two presidential terms.

　　　　A source close to Putin’s office said: "For more than two years, the outside world has always believed that Putin will withdraw from Russian politics after his term ends. But now earth-shaking changes have taken place. " "There is no doubt that Putin now wants to stay in politics, either as prime minister or return to the presidency. Such a move has also been supported by Russian political circles and most people. "

　　　 On October 1, Russian President Vladimir Putin spoke at the Eighth Congress of the United Russia Party held in Moscow. On the same day, Putin said that he would lead the United Russia Party campaign group to participate in the new State Duma (lower house of parliament) election on December 2, but he refused to become a member of the party. Xinhua News Agency/AFP

　　　　Putin may amend the constitution after becoming prime minister

　　　　Russia’s "power tycoon" had hoped to keep Putin as president by amending the constitution, but Putin himself did not agree with this practice. Putin said that he hopes to extend the term of a single president to five or seven years, but he will not amend the constitution during his presidency.

　　　　It is speculated that Putin’s statement implies that he will amend the constitution after becoming prime minister. Theoretically, Putin can serve as president for another 14 years after the constitutional amendment. If this plan is finally realized, Putin will serve as Russian president for 22 years.

　　　　Experts say that even as prime minister, Putin can remain in power, and all he needs to do is to transfer part of the president’s power to the prime minister through parliamentary voting. Zubcov, the new Russian Prime Minister, was previously regarded as a popular candidate for the next president. However, due to the lack of power base, Zubcov is likely to be just a "caretaker" of the government.

　　　　The "Putin era" has just begun

　　　　Nikonov, head of the Russian government think tank, said: "At present, it is only the beginning of the Putin era." The famous Russian political critic Pozner said: "Most Russians hope that Putin will continue to serve as president. They believe that Putin has brought them pride again. "

　　　　During his presidency, Putin has brought great changes to Russia, avoiding the turmoil that occurred in Latin American countries in Russia. For example, in saratov, a small town near Moscow, commerce has gradually begun to be established, and manufacturing industries, including furniture factories, can also meet the daily consumption needs of local residents. These developments have solved the problems that have existed since the Soviet era. In addition, local universities are equipped with the best computers, and agriculture has also improved.

　　　　One of Putin’s most important achievements is that the shadow brought by the Chechen issue has gradually dissipated under the guidance of a series of policies. Some media who "don’t like" Putin also admit that Grozny, the capital of Chechnya, has finally begun the process of reconstruction after 20 years of turmoil. The local tourism in Chechnya is also developing vigorously at present, and the tension caused by Chechen terrorists has become a thing of the past.

　　　　The commentary believes that if the Russian people affirm Putin’s political achievements and Russia is indeed in the process of re-emergence, then Putin, as a successful president, has every reason to extend his term again. (Zhong Long)

Editor: Li Xiuwei

On the evening of November 12th, BYD and Huawei jointly released the equation Leopard 8, and released four models, including Zhiyong flagship six-seat version of 407,800 yuan, Zhiyong flagship seven-seat version of 399,800 yuan, Zhiyong luxury six-seat version of 387,800 yuan and Zhiyong luxury seven-seat version of 379,800 yuan.

BYD officially said that one Leopard 8 is equal to four ace technologies, multiplied by one set of luxury configuration enjoyed by the whole family and one non-loaded hard-core body, leading a new lifestyle and opening a new era of global intelligent hard-core with the extraordinary strength of "wisdom and courage".

It is understood that Leopard 8 is equipped with a high-level intelligent driving scheme — — Huawei’s intelligent driving of ADS 3.0 can realize the whole scene of "parking space to parking space", and can independently deal with complex scenes such as gates, turning around the island and turning around in narrow lanes, and support various intelligent parking functions such as parking, parking and driving, and remote moving.

In addition to intelligent driving, some Leopard 8 in the cockpit is also equipped with the exclusive AI intelligent cockpit of Equation Leopard, which adopts BYD 9000 chip with 4nm advanced process and integrates the intelligent voice and intelligent image of AI model. In addition, Leopard 8 also supports the "Fanghua" handcart interconnection function. Through HUAWEI HiCar connection, the applications and services on Huawei mobile phones can be extended to the car, including the industry’s first navigation and circulation capabilities.

In terms of product performance, Leopard 8 is equipped with BYD’s full-featured Yunqi -P hydraulic suspension, which is the same as that of millions of high-end brands. It is understood that Yunqi -P system integrates three core technologies of machinery, hydraulics and electronic control, and has three major functions including maximum suspension stroke height of 140mm, three-level stiffness and intelligent damping, as well as active preview and four-wheel linkage, which can greatly improve the stability of vehicle driving.

At the same time, Leopard 8 is also equipped with Equation Leopard’s exclusive DMO electric drive off-road pioneering platform (2.0T top version), which is a hybrid platform with electricity as the mainstay and both urban and rural areas. It is homologous to BYD’s latest DM 5.0 plug-in technology platform and has the characteristics of "strong power, strong passability and strong security".

The comprehensive power of the system can reach 550kW, the maximum torque is 760N·m, the maximum horsepower is nearly 750 horsepower, the acceleration per 100 kilometers is 4.8s, and the fuel consumption per 100 kilometers is 8.5L L.

It is worth noting that in terms of configuration, Equation Leopard 8 is also equipped with 200+ configuration as standard. Leopard 8 cockpit integrates a set of luxurious configuration for the whole family to enjoy, and "refrigerator, color TV and big sofa" are all available. In addition, the Leopard 8 car supports the 7-screen linkage function and is equipped with a compressor of -6 to 50℃ to cool and warm the refrigerator.

In terms of passive safety, Leopard 8 is equipped with BYD blade battery; The whole vehicle adopts five-star safety design; At the same time, 14 airbags and pre-tensioned seat belts of front motors are standard. In terms of active safety, thanks to the omni-directional anti-collision ability of Huawei Gankun Intelligent Driving ADS 3.0, Leopard 8 supports higher braking speed and shorter braking distance, and has the anti-collision function of stepping on the accelerator pedal by mistake.

Due to the large size of hard-core models, Leopard 8 not only supports parking, users can leave the car by choosing a parking space on the car machine, but also supports parking on behalf of the driver and remote moving the car. Through mobile phone control, intelligent parking assistance can help users solve the problem that it is difficult to park a large car with a narrow parking space.

According to the official introduction, up to now, Equation Leopard has added 115 stores nationwide since its brand rejuvenation and channel opening, with a total of 300 stores covering 133 cities nationwide.

Original title: On May Day, the video of A Xin’s live jumping subject III was shocked and exposed, showing his love and passion for music.

Hey, friends, have you paid attention to the New Year’s concert on May Day recently? At the "Back to that Day" concert in Taichung, lead singer A Xin performed a stunning video of dance subject III, which was really shocking! The difficulty coefficient of this dance is very high, which is beyond the control of ordinary dancers. When A Xin dances this dance, we can really feel his love for music and passionate attitude. His dance steps are smooth and natural, and every movement is full of strength and rhythm, which makes people excited. This performance once again proves Mayday’s strength and good stage charm. Let’s look forward to their wonderful performance in the future!

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Editor in charge:

　　央视网消息：据教育部网站信息，日前，教育部等五部门印发《关于进一步加强和规范教育收费管理意见》的通知（简称《通知》），要求各地按照规定的管理权限全面落实教育收费管理主体责任，正确处理好政府与社会、受教育者的关系，正确处理好教育收费与财政拨款、学生资助的关系，正确处理好简政放权和放管结合、优化服务的关系，进一步完善教育收费政策体系、制度体系、监管体系，提升教育收费治理能力。

　　关于进一步加强和规范教育收费管理的意见

　　党中央、国务院历来高度重视教育收费管理工作，自全国治理教育乱收费部际联席会议制度建立以来，在各有关部门、地方各级政府的共同努力下，教育收费水平保持了基本稳定，教育乱收费现象得到了有效遏制。但随着经济社会的发展，教育收费管理工作在体制机制、政策执行、监督管理等方面仍然存在一些问题，与教育改革发展的需要和人民群众的期待仍然存在一定差距。为贯彻落实《中国教育现代化2035》《国务院办公厅关于进一步调整优化结构 提高教育经费使用效益的意见》等文件精神，进一步加强和规范教育收费管理，现提出以下意见。

　　一、总体要求

　　（一）指导思想

　　以习近平新时代中国特色社会主义思想为指导，全面贯彻落实党的十九大和十九届二中、三中、四中全会精神，深入贯彻落实全国教育大会精神，始终坚持把教育事业摆在优先位置，主动适应教育、财税、价格等领域改革新要求，巩固完善以政府投入为主、多渠道筹集教育经费体制，逐步完善各级各类教育投入机制和非义务教育培养成本分担机制，建立健全教育收费政策体系、制度体系、监管体系，提升教育收费治理能力，持续巩固教育乱收费治理成果，促进教育公平而有质量的发展。

　　（二）基本原则

　　——坚持公益属性、分类管理。坚持教育的公益性，充分发挥政府对教育事业的主导作用。区分义务教育和非义务教育的不同阶段，区分非营利性和营利性民办教育的不同属性，正确处理政府与社会、受教育者之间的关系，合理分担教育培养成本。

　　——坚持分级审批、属地管理。教育领域行政事业性收费项目、标准实行中央和省两级审批，中央部门所属学校收费标准实行属地管理。各省、自治区、直辖市（以下简称各省）按照规定的管理权限，科学制定收费政策，加强收费项目管理，合理确定收费标准，全面落实教育收费管理主体责任。

　　— — Adhere to problem orientation, reform and innovation. Constantly improve the management system of education fees, improve the policy of education fees, strengthen the management of fees in key areas and key units, focus on solving the problems of fees system and mechanism that are incompatible with the reform and development of education, and focus on solving the problems of fees that are strongly reflected by the masses. Administer education in an all-round way according to law, adhere to administration and financial management according to law, strengthen supervision after the event, combine daily supervision with special supervision, and innovate the way of charging supervision.

　　Second, improve the education charging policy

　　(3) Adhere to the nine-year compulsory education system. Compulsory education is fully included in the scope of financial security, and public compulsory education schools do not charge tuition and miscellaneous fees. All localities should strictly implement the compulsory education law, consolidate and improve the funding guarantee mechanism for compulsory education in urban and rural areas, adhere to the nine-year compulsory education system, and prohibit arbitrarily expanding the implementation scope of the free education policy. The standard of exempting students from tuition and miscellaneous fees in private compulsory education schools is implemented according to the benchmark quota of public funds per student; For the part with insufficient per capita education and training cost, we should strictly implement the non-profit statutory requirements and reasonably determine the charging standard. It is strictly forbidden to collect donations linked to enrollment. In accordance with the relevant provisions of the state, schools or other social organizations that recruit students in the compulsory education stage to carry out professional training in literature, art and sports should not include tuition and fees that students are exempted from after completing the nine-year compulsory education course.

　　(four) adhere to the implementation of non compulsory education training cost sharing mechanism. Non-compulsory education implements the input mechanism of government investment, reasonable sharing by the educated and financing from other channels. According to the cost of running a school, the level of economic development and the financial situation, all provinces should implement and dynamically adjust the per capita financial allocation standard or the per capita public funding standard for public kindergartens, ordinary high schools, secondary vocational schools, higher vocational colleges and ordinary undergraduate colleges. Schools (including kindergartens, the same below) charge tuition fees (conservation education fees) to the educated according to a certain proportion of the annual average cost of education and training, and charge accommodation fees to boarding students in consideration of actual costs (excluding financial allocations). Students with financial difficulties in families enjoy the policy of reduction and exemption in accordance with relevant state regulations. All provinces should reasonably determine the proportion of tuition fees (conservation education fees) of public kindergartens, ordinary high schools and secondary vocational schools to the annual average education and training costs in light of local conditions. At present, the proportion of tuition fees in public institutions of higher learning to the annual average cost of education and training should not exceed 25%, and all localities should reasonably determine it according to the level of economic and social development, training costs and people’s affordability.

　　Kindergartens run by the army that recruit children of local personnel and enjoy subsidies from the local people’s government shall be charged in accordance with the relevant provisions of public kindergartens; Those who do not enjoy subsidies shall be specifically formulated by the army in accordance with relevant state policies, and the charging standards shall be reasonably determined. The charging policies for Chinese-foreign cooperative education and part-time postgraduate education shall be formulated by the provinces.

　　(5) Adhere to the classified management of private education fees. According to the relevant provisions of the Law on the Promotion of Private Education, the specific measures for charging non-profit private schools shall be formulated by the provincial people’s government; The charging standards of for-profit private schools shall be regulated by the market and decided by the schools themselves. The charging standard of inclusive private kindergartens is determined reasonably according to the administrative measures for the identification of inclusive private kindergartens promulgated by provincial people’s governments, taking into account the charging levels of public kindergartens and inclusive private kindergartens as a whole, and taking into account factors such as the level of economic development, the affordability of the masses, the cost of running parks and the level of financial subsidies. All localities should speed up the formulation and implementation of financial subsidy standards for inclusive private kindergartens, implement public subsidies for private schools in the compulsory education stage, strengthen the regulation of charging standards, and resolutely prevent excessive fees. Private schools established before November 7, 2016 shall be managed as non-profit private schools before completing the relevant procedures for classified registration.

　　(six) improve the school service charges and fees and other policies. In addition to completing the normal tasks of conservation, education and teaching, the school provides students with relevant convenient services needed for study and life, and organizes activities such as study tours, after-school services and social practice. For the part borne by students or their parents, service fees can be charged according to the principles of voluntariness and non-profit. If the relevant services are provided by institutions or individuals outside the school, the school may collect and pay the relevant fees. The specific policies on school service charges and agency charges shall be formulated by the provinces. Projects that have been explicitly prohibited by the state or explicitly stipulated by the financial guarantee shall not be included in service charges and fees on behalf of the school. Schools shall not set up service charges and fees on behalf of the school without authorization, and shall not obtain the difference in the fees collected. They shall not force or imply students and parents to buy designated teaching AIDS or materials, and shall not charge related fees by starting classes in advance or in disguised form. In-school student dormitories and off-campus student apartments organized by social forces are not allowed to provide relevant life services or bundle service charges with accommodation fees. The school’s self-operated canteen shall collect meals from students who voluntarily dine, and shall adhere to the principle of public welfare and shall not be for profit.

　　(7) Improve the charging policy for overseas Chinese students from Hong Kong, Macao and Taiwan studying in the mainland (the mainland of the motherland). For students from Hong Kong, Macao and Taiwan who study in the mainland (the mainland of China) and overseas Chinese students who study in primary and secondary schools and kindergartens, the same charging policy as that for mainland students (the mainland of China) shall be implemented in accordance with relevant regulations; Admission to the mainland (the mainland) ordinary colleges and universities and research institutes, in accordance with the relevant provisions of the implementation of the same fees as the mainland (the mainland) students.

　　(eight) improve the international student fee policy. For international students studying in public primary and secondary schools and kindergartens, the charging policies shall be formulated by the provinces. The school charging policy for children of foreigners shall be formulated by the school independently. The charging standard for self-funded international students in China accepted by colleges and universities is reasonably determined by the school according to the local economic and social development level and training cost, so as to avoid vicious competition. According to the agreement between the Chinese government and the sending country, the charging policy for students who come to China for education shall be implemented in accordance with relevant regulations.

　　Third, improve the management system of education fees

　　(nine) to establish and improve the dynamic adjustment mechanism of education fees. All localities should, in accordance with the prescribed management authority and the principle of territorial management, comprehensively consider factors such as the level of economic and social development, the cost of education and training, and the affordability of the masses, reasonably determine the charging standards for tuition fees (conservation and education fees) and accommodation fees of public schools, and establish a dynamic adjustment mechanism for charging standards that is compatible with the level of funding and funding. If there is any change in the school charging policy, it should be publicized to the public before the release of the enrollment brochure. Encourage all localities to adapt to the teaching organization mode under the flexible academic system and explore the implementation of credit system charge management in colleges and universities. In schools that have been approved to implement credit system fees, the total tuition fees paid by students who normally complete their studies according to the credit system training program shall not be higher than the total tuition fees for the implementation of the academic year system in principle, and other professional courses are added or re-courses are re-taken. Schools can charge fees according to the credit charging standards stipulated in the courses. Tuition and accommodation fees shall be charged according to the academic year or semester, and shall not be collected in advance across academic years (semesters). If students drop out of school, drop out of school, finish their studies early or transfer with approval, the school should reasonably determine the amount of refund according to the actual study time. All localities should fully implement the state’s various financial aid policies, help students with financial difficulties to solve practical problems, and must not affect their normal study and life because of the adjustment of tuition standards.

　　(ten) to strengthen the education and training cost investigation. Timely revise and improve the Measures for the Supervision and Examination of Education and Training Costs in Colleges and Universities (Trial), and organize the supervision and examination of the annual average education and training costs in colleges and universities. In accordance with the pricing authority, according to the Price Law, the Measures for the Supervision and Examination of Price Costs Formulated by the Government, etc., combined with local conditions, all provinces actively carry out the investigation of education and training costs in kindergartens, ordinary high schools and secondary vocational schools, and standardize the investigation behavior of education and training costs. Schools at all levels and of all types should strengthen cost accounting, and record and account the education and training costs completely and accurately.

　　(eleven) standardize the hearing system of education fee decision. All localities should formulate or adjust tuition fees and other charging standards of various schools at all levels organized by the government in strict accordance with the authority and procedures prescribed by the state, include them in the catalogue of pricing hearings and conduct hearings, fully solicit opinions from relevant sectors of society, and ensure the democratic, scientific and transparent decision-making on education fees. If the standard of education fees is lowered, or the adjustment of the standard of education fees involves a small area, the hearing may adopt a summary procedure. To formulate other educational charging standards, and if necessary, a hearing can also be held.

　　(twelve) strictly implement the publicity system of education fees. All localities should strictly implement the publicity system of education fees, and no fees shall be charged without publicity. All kinds of schools at all levels should establish and improve the standardized dynamic management system of charge publicity and take the initiative to accept social supervision. The charging items and standards should be publicized to students in a prominent position in the school, and indicated in the enrollment brochure and the admission notice. In the compulsory education stage, the charging standard of private schools should be publicized together with the subsidy of public funds per student obtained by schools. Students have the right to refuse to pay fees that should be publicized but not publicized according to the regulations, or fees that are inconsistent with the prescribed policies. When the charging policy changes, the school should update the publicity content in time to ensure that the publicity content is legal and effective. All localities should strictly implement the list of administrative fees such as education fees, and shall not increase the fees and expand the scope of fees without authorization.

　　(thirteen) to strengthen the management of education fees. Tuition and accommodation fees of public ordinary high schools and secondary vocational schools, tuition fees, accommodation fees, entrusted training fees of public institutions of higher learning, night and short-term training fees of Handu Radio and TV University, etc., as business income, are included in the financial special account management according to the requirements of "two lines of revenue and expenditure". Public kindergarten fee income management according to the existing regulations. Service fee income shall be charged by the school according to the regulations; On behalf of the school fee income all transferred to provide services units, shall not be included in the school income. Schools should incorporate all the income and expenditure of education fees into departmental budget management and increase the overall planning of funds; The expenses related to the arrangement of education fees shall be included in the standardized management of the project library according to the regulations. Combined with other income such as education fees, we will make overall arrangements for the budget of financial allocation to give better play to the efficiency of the use of financial funds. All localities shall not use the school fee income to balance the budget, and shall not occupy, intercept, transfer or misappropriate the school fee funds in any form. Private school fee income should be paid into the school bank account filed by the education administrative department for unified management, which is mainly used for education and teaching activities, improving school conditions and ensuring the treatment of faculty and staff, and drawing development funds according to relevant laws and regulations. When collecting administrative fees, schools should use the financial bills printed (supervised) by the financial department in accordance with the financial affiliation, use the corresponding tax invoices when collecting service fees, and use the fund settlement bills when collecting fees.

　　Fourth, strengthen the governance of education fees

　　(fourteen) the implementation of education fees supervision responsibility. Education fees adhere to the principle of "who approves and who is responsible". The member units of the joint conference on the control of arbitrary charges in education shall, according to their respective responsibilities, incorporate education charges into the catalogue management, adjust them dynamically in a timely manner and announce them to the public in a timely manner, and supervise the implementation of relevant charging items and charging standards according to law; Strengthen the cost investigation of education fees, and establish and improve the dynamic adjustment mechanism of fees; Strengthen the supervision and inspection of fees in the field of education, and investigate and deal with illegal fees according to law; Strengthen the price management of teaching materials and supplementary materials; Guide schools at all levels to implement the education charging policy and standardize the charging behavior. All kinds of schools at all levels should strictly implement the prescribed charging scope, charging items, charging standards and charging methods, and establish and improve the school charging management system.

　　(fifteen) improve the management mechanism of education fees. All localities should attach great importance to the management of education fees, establish and improve the leadership system and working mechanism, and persist in systematically promoting the management of education fees. The member units of the joint meeting of the local governments to control unreasonable charges in education should make overall coordination, improve the mechanism of regular consultation and information release, form a work pattern of charge management with clear responsibilities, collaborative linkage and mutual promotion, and strengthen the governance of education charges in key areas. It is necessary to bring the management of education fees into the scope of education supervision. Explore the establishment of a special audit system for school fees, focus on strengthening the audit of non-profit private schools, and prohibit the organizers of non-profit private schools and non-profit Chinese-foreign cooperatively-run schools from obtaining income from school-running income such as tuition fees, distributing school-running balance (surplus property) or transferring school-running income through related transactions and related parties in various ways.

　　(sixteen) to increase the investigation and punishment of illegal charges. All localities should strengthen the daily supervision and regular inspection of education fees, establish and improve the risk early warning of education fees, acceptance of letters and visits, supervision and supervision, public notification and interview mechanisms, and seriously deal with the problems of illegal fees found. Establish and improve the accountability mechanism, the main responsibility of charge management is not implemented, measures are not in place, damage the vital interests of the masses, resulting in adverse social impact of the units and related responsible persons should be seriously accountable. If the illegal charges of private schools have a bad influence, the enrollment plan and financial support funds will be deducted according to the law until the school license is revoked or revoked.

　　(seventeen) to strengthen the basic capacity building of education fee management. Implement the "National Education System Financial Management Cadre Training Implementation Plan", organize and carry out education fee management training, and improve the ability and level of education fee management. All localities should make full use of modern information technology, explore the establishment of an annual statistical reporting system for education fees, strengthen the management of education fees, further strengthen service awareness, and improve service capacity and level.

　　The management of educational fees in scientific research institutes and party schools at all levels shall be implemented with reference to this opinion, and the policies for the management of fees in institutions affiliated to education departments at all levels shall be formulated separately.